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The Effects of Massage and Exercise Therapy on Walking, Balance, Quality of Life, Fatigue, Spasticity and Pain in Multiple Sclerosis

Protocol summary

Summary
The aim was to evaluate the effects of massage therapy on pain, fatigue, spasticity, balance, gait, and quality of life in patients with multiple sclerosis and compare with effects after exercise therapy or massage-exercise therapy. In this Single Blinded Randomized Controlled Trial 48 patients RR MS OR SP MS with EDSS between 2-6 were randomly assigned to four subgroups as MT, ET, MET or control group. Patients received three 30 min intervention per week for five weeks. The MT group received a standard Swedish massage. Included in the ET group were a combined set of strength, stretch, endurance, and balance training. Patients in the MET received a combined set of massage-exercise. Patients in the control group were asked to continue their standard medical care. Examiner was blinded to grouping. Patients in study were blinded to existence of other groups and therapies. Outcome measurement were assessed pre-intervention and immediately after intervention completion. Primary outcome measures included: EDSS, Spasticity, Fatigue Severity, Pain, Quality of Life, Static Balance, Dynamic Dalance, Gait Velocity, Gait Endurance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051413335N1
Registration date: 2013-07-20, 1392/04/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Solmaz Rezaie
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 7823
Email address
rezaie.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Massage and Exercise Therapy on Walking, Balance, Quality of Life, Fatigue, Spasticity and Pain in Multiple Sclerosis
Public title
The effect of massage and Exercise Therapy in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria to study: Confirm MS with neurologist; RR MS OR SP MS; EDSS between 2-6; Ability to walk with or without assist; Ability to stand with or without assist; Absence any Underlying disease include: Rheumatic disease, Orthopedic Diseases, Metabolic diseases or other neurologic diseases; Non-use antispastic drags; Women in study Not to be pregnant; Patients haven't open or infected wounds on skin; Patients Don't participate in other studies; Patients have no Recurrence in 6 month ago Major exclusion criteria to study: Severe or suddenly neurologic symptoms
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, University city, Ahvaz
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-494

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis

Primary outcomes

1

Description
EDSS
Timepoint
before intervention and after 15 session intervention
Method of measurement
Expanded Disability Severity Status-numerical

2

Description
Spasticity
Timepoint
before intervention and after 15 session intervention
Method of measurement
Modified ashworth scale- numerical

3

Description
Fatigue Severity
Timepoint
before intervention and after 15 session intervention
Method of measurement
Fatigue Severity Scale

4

Description
Pain
Timepoint
before intervention and after 15 session intervention
Method of measurement
Visual Analogue Scale

5

Description
Quality of Life
Timepoint
before intervention and after 15 session intervention
Method of measurement
Quality of Life Multiple Sclerosis -54

6

Description
Static Balance
Timepoint
before intervention and after 15 session intervention
Method of measurement
Berg Balance Scale

7

Description
Dynamic Balance
Timepoint
before intervention and after 15 session intervention
Method of measurement
Timed Up and Go-Ssecond

8

Description
Gait Velocity
Timepoint
before intervention and after 15 session intervention
Method of measurement
Timed 10-meter Walk-Second

9

Description
Gait Endurance
Timepoint
before intervention and after 15 session intervention
Method of measurement
2-Mintue Walking-Meter

Secondary outcomes

empty

Intervention groups

1

Description
Control Group-continue medical care and usual physical therapy program be done with delay and after 5 weeks
Category
Other

2

Description
Massage Group- swedish massage for lower extremity for 30 minutesin per session during 15 sessions in 5 weeks
Category
Treatment - Other

3

Description
Exercise Group-exercises for 30 minutesin per sessions for 15 sessions during 5 weeks-exercises include: 1.Weighted Straight Leg Rising 2.Forward Lunge 3.treadmill treaning 4.progressive resistance cycling 5.balancing exercise 6.stretching exercise
Category
Rehabilitation

4

Description
Massage and Exercise Group- combination of 15 minutes massage of lower extremity and 15 minutesexercise therapy for 15 sessions during 5 weeks- exercises include: 1.Weighted Straight Leg Rising 2.Forward Lunge 3.treadmill treaning 4.progressive resistance cycling 5.balancing exercise 6.stretching exercise
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khuzestan Community of Multiple Sclerosis
Full name of responsible person
Solmaz Rezaie
Street address
Ground Floor, Faculty of Rehabilitation Sciences ,Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ground Floor, Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
Master Degree in Physical Therapy
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1333 3477
Fax
Email
rezaie.s@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
Master Degree in Physical Therapy
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1333 3477
Fax
Email
rezaie.s@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
Master Degree in Physical Therapy
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1333 3477
Fax
Email
rezaie.s@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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